Senior Quality Assurance Associate Operations Lead
4 days ago
Transforming Healthcare with Baxter
Baxter is a global pharmaceutical company dedicated to saving and sustaining lives. We are seeking a highly skilled Senior QA Associate Operations Lead to join our team in Elstree, UK.
Main Responsibilities:
- Support the batch review process to ensure flawless quality.
- Release raw materials and components for processing, and finished product to market.
- Investigate non-conformances, CAPAs, and complaints to maintain compliance with ISO13485 and FDA (21 CFR) part 820.
- Compile release data for finished products, including product bioburden, sterilisation, and test results.
- Collate, review, and complete batch documentation to support release.
- Ensure closure of deviations prior to release to ensure timely release of product.
- Document control: Support document control activities, responsibility for filing/archiving completed DHRs and batch/order documentation.
- Deviation management: Support quality investigations to support release of finished product.
- Liaise with Baxter, Elstree staff and sub-contractors to carry out investigations.
- Quality Assurance/Control: Adhere to Baxter, Elstree relevant policies and procedures at all times.
- Support all aspects of the QMS through participation in internal audit and supplier audits.
- Support investigations into incidents such as complaints, and any subsequent field correct actions/recalls.
- Support regulatory inspections as required.
- Support change control projects, new product development projects, sterilisation validations, endotoxin testing, environmental monitoring, and purified water testing.
- Manage the statistical process control (SPC) process for review of manufacturing and quality data.
- Administrative tasks for supplier quality QMS, creation of part numbers, and update of Bill of Materials.
- Participate in cross-functional project teams and attend meetings as a representative of Quality.
Requirements:
- Degree or equivalent qualification in a scientific, technical, or engineering subject desired but not essential if you can demonstrate 2+ years experience in a GMP environment.
- Experience working to ISO13485, FDA (21 CFR) part 820 or GMP (Orange Guide) compliant systems.
- Experience in reviewing and releasing finished product to market or for final disposition.
- Quality investigational tool training.
- Familiarity with NCR/CAPA, document control processes within a regulated QMS, and auditing.
- QA experience in cleanroom environments – sterile/aseptic manufacturing.
- Field of expertise: QA, cGMP, and Quality Systems in an Operational Quality environment.
- Knowledge of clean room control requirements.
- Excellent communication skills.
About Baxter:
Baxter is a global leader in medical innovation, with a rich history of pioneering significant medical innovations that transform healthcare. Our products and therapies are found in almost every hospital worldwide, in clinics, and in the home. We are committed to saving and sustaining lives, and your work will have a direct impact on millions of patients globally.
Join Us:
Are you ready to make a difference in the world? Join Baxter Healthcare Corporation as a Senior QA Associate Operations Lead in Elstree, UK. We offer a collaborative environment, a passion for delivering exceptional results, and a commitment to saving and sustaining lives.
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St Albans, Hertfordshire, United Kingdom Baxter Full timeTransforming Healthcare through Quality ExcellenceBaxter, a global leader in pharmaceuticals, is seeking a highly skilled Senior QA Associate Operations Lead to join our Elstree, UK team. As a key member of our world-class manufacturing operations, you will play a crucial role in ensuring the highest quality standards are met.Main Responsibilities:Support...
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St Albans, Hertfordshire, United Kingdom Baxter Full timeTransforming Healthcare through Quality ExcellenceBaxter, a global leader in pharmaceuticals, is seeking a highly skilled Senior QA Associate Operations Lead to join our Elstree, UK team. As a key member of our world-class manufacturing operations, you will play a crucial role in ensuring the highest quality standards are met.Main Responsibilities:Support...
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St Albans, Hertfordshire, United Kingdom Baxter Full timeAbout BaxterBaxter is a global pharmaceutical company dedicated to saving and sustaining lives. Our mission is to improve patient outcomes through innovative medical solutions.Job SummaryWe are seeking a Senior QA Associate Operations Lead to join our team in Elstree, UK. As a key member of our operations team, you will play a crucial role in ensuring the...
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St Albans, Hertfordshire, United Kingdom Baxter Full timeAbout BaxterBaxter is a global pharmaceutical company dedicated to saving and sustaining lives. Our mission is to improve patient outcomes through innovative medical solutions.Job SummaryWe are seeking a Senior QA Associate Operations Lead to join our team in Elstree, UK. As a key member of our operations team, you will play a crucial role in ensuring the...
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St Albans, Hertfordshire, United Kingdom Baxter Full timeAbout BaxterBaxter is a global pharmaceutical company dedicated to saving and sustaining lives. Our mission is to improve healthcare outcomes for millions of patients worldwide.Job SummaryWe are seeking a Senior Quality Assurance Associate Operations Lead to join our team in Elstree, UK. As a key member of our operations team, you will play a crucial role in...
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St Albans, Hertfordshire, United Kingdom Baxter Full timeTransforming Healthcare with BaxterBaxter is a global pharmaceutical company dedicated to saving and sustaining lives. We are seeking a highly skilled Senior QA Associate Operations Lead to join our team in Elstree, UK.Main Responsibilities:Support the batch review process to ensure flawless quality.Release raw materials and components for processing, and...
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